DeviceClearance

RX-1 Rhythm Express Remote Cardiac Monitoring System— 510(k) K183704

Substantially Equivalent

VivaQuant, Inc.

FDA 510(k) clearance K183704 for RX-1 Rhythm Express Remote Cardiac Monitoring System, Substantially Equivalent on 2019-02-16. Applicant: VivaQuant, Inc.. Device class: 2.

Clearance details

Applicant
VivaQuant, Inc.
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.